Recruiting

Ublituximab

Sponsor:

Johns Hopkins University

Code:

NCT07389590

Conditions

Multiple Sclerosis

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

Ublituximab

Ocrelizumab

Study Details

Brief summary:

The proposed study is a pilot study of ublituximab involving people with multiple sclerosis (MS) who are experiencing a "wearing off" phenomenon (return or worsening of MS-related symptoms) while being treated with ocrelizumab, and exploring whether switching to ublituzimab can resolve, improve or delay this phenomenon.

Conditions

Multiple Sclerosis

Study ID

NCT07389590

Start date

Feb 10, 2026

Status verified date

May, 2026

Completion date

Mar, 2029

Anticipated

Primary completion date

Oct, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Patients with relapsing forms of MS.
  • Age between 18 and 65 years old (inclusive).
  • On treatment with standard interval ocrelizumab for at least one year.
  • Eligible and willing to continue treatment with ocrelizumab or ublituximab.
  • The presence of wearing off phenomena, defined as either worsening in any Neuro-QoL sleep disturbance, fatigue, depression, upper and lower extremity scores (moving from a lower category of symptom severity to a higher category, based on previously defined cutoff scores), a worsening of Neuro-QoL score of 10 points (which equals 1 SD) or more in any domain between a 1-2 month post-infusion assessment (after one ocrelizumab infusion) and a 1-2 month pre-infusion assessment (before the next scheduled infusion).

Exclusion Criteria:

  • Prior therapy: Has ever received any of the following:

  • B-cell targeted therapies: rituximab, ofatumumab, ublituximab or other anti-CD20 agents besides ocrelizumab.
  • Prior use of cladribine, alemtuzumab, mitoxantrone, cyclophosphamide or HSCT.
  • Lymphopenia: a lymphocyte count <500/ millimeter (mm)\^3. Historical labs may be used if the collection date is 6 months or less prior to deeming eligible.
  • Neutrophils <1.5X10E9/L. Historical labs may be used if the collection date is 6 months or less prior to deeming eligible.
  • Clinically unstable medical or psychiatric disorder.
  • Substance abuse: has evidence of current drug or alcohol abuse or dependence.
  • 365 Day prior therapy: has received a biologic investigational agent other than B-cell targeted therapy \[e.g., anti CD40L antibody\].
  • Malignancy: has a history of malignancy in the past 5 years except for adequately treated cancers of the skin (basal or squamous cell) or carcinoma in situ of the uterine cervix.
  • Have a history of a primary immunodeficiency.
  • Have a significant IgG deficiency (IgG level < 400 mg/dL).
  • Have an IgA deficiency (IgA level < 10 mg/dL).
  • Infection history:

  • Currently on any suppressive therapy for chronic infection (such as tuberculosis, pneumocystis, cytomegalovirus, herpes simplex virus, herpes zoster, and atypical mycobacteria).
  • Hospitalization for treatment of infection within 60 days of Screening.
  • Use of parenteral (IV or IM) antibiotics (anti-bacterial, antiviral, anti-fungal, or anti-parasitic agents) within 60 days of Screening.
  • Other disease/conditions: has any of the following: a) clinical evidence of significant unstable or uncontrolled acute or chronic diseases (i.e., cardiovascular, pulmonary, hematologic, gastrointestinal, hepatic, neurological, malignancy or infectious diseases) which, in the opinion of the investigator, could confound the results of the study or put the subject at undue risk.
  • Hepatitis status:

  • Serologic evidence of current or past Hepatitis B (HB) infection based on the results of testing for HBsAg and HBcAb as follows: Patients positive for HBsAg or HBcAb are excluded.
  • A positive test for Hepatitis C antibody
  • HIV: known to have a historically positive HIV test or tests positive at screening for HIV.
  • Laboratory abnormalities: An abnormal laboratory assessment is made, which is judged clinically significant by the investigator.
  • Drug Sensitivity: has a history of sensitivity to any of the study medications.
  • Any contraindication to undergoing MRI.
  • TB: tests positive at screening for tuberculosis.
  • Impaired decision-making capacity or impaired ability to provide informed consent.

Study Design

Enrollment

50 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Ublituximab

Participants in this arm will switch from Ocrelizumab to receive Ublituximab administered intravenously (IV) as cumulative dose of 450-milligram (mg) infusions every 6 months for at least 2 doses.

active comparator: Ocrelizumab

Participants in this arm will continue to receive Ocrelizumab administered intravenously (IV) as 600-milligram (mg) infusions every 6 months for at least a further 2 doses.

Interventions

Ublituximab

Ublituzimab will be administered via IV infusion as specified throughout the study period.

Ocrelizumab

Ocrelizumab will be administered via IV infusion as specified throughout the treatment period.

Primary outcome measure

  • Proportion of Patients with Wearing-Off [ Time Frame: From month 1 up to 11 months ]

Central Contacts and Locations

Central contacts

Ziyun Research Program Coordinator

410-614-1522zwang306@jhu.edu

Locations

Johns Hopkins University

Recruiting

Baltimore, Maryland, United States, 21287

More Information

Sponsor

Johns Hopkins University

Last update posted

May 6, 2026

Last verified

May, 2026

Keywords

  • wearing off
  • ocrelizumab
  • ublituximab

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Johns Hopkins University on 2026-05-06.